scholarly journals Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial

Author(s):  
Christiane Maria Prado Jeronimo ◽  
Maria Eduarda Leão Farias ◽  
Fernando Fonseca Almeida Val ◽  
Vanderson Souza Sampaio ◽  
Marcia Almeida Araújo Alexandre ◽  
...  

Abstract Background Steroid use for coronavirus disease 2019 (COVID-19) is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. Methods A parallel, double-blind, placebo-controlled, randomized, Phase IIb clinical trial was performed with hospitalized patients aged ≥18 years with clinical, epidemiological, and/or radiological suspected COVID-19 at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution) twice daily for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. Results From 18 April to 16 June 2020, 647 patients were screened, 416 were randomized, and 393 were analyzed as mITT, with 194 individuals assigned to MP and 199 to placebo. SARS-CoV-2 infection was confirmed by reverse transcriptase polymerase chain reaction in 81.3%. The mortality rates at Day 28 were not different between groups. A subgroup analysis showed that patients over 60 years old in the MP group had a lower mortality rate at Day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until Day 7. Conclusions The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population. Clinical Trials Registration NCT04343729.

2021 ◽  
pp. 000348942110457
Author(s):  
Mohamad Issa ◽  
Nadeem El-Kouri ◽  
Sara Mater ◽  
Jonathan Y. Lee ◽  
Carl Snyderman ◽  
...  

Introduction: The concept of a hospitalist has been well established. This model has been associated with reduced length of stay contributing to reduction in healthcare costs. Minimal literature is available assessing the effects of an otolaryngology (ENT) hospitalist at a tertiary medical center. The aim of this study is to assess the role of an ENT hospitalist on (1) performing tracheostomies and (2) providing care as part of the tracheostomy care team (TCT). Methods: Retrospective chart review of all tracheostomies performed by the ENT service over 2 years (July 2015-June 2017), and prospective data collection of all tracheostomy care consults over 1 year (July 2016-June 2017). In year 1 (from July 2015 to June 2016), no ENT hospitalist was employed, and in year 2 (from July 2016 to June 2017), an ENT hospitalist was employed. Results: Compared to other Ear, Nose, and Throat (ENT) surgeons, the ENT hospitalist performed tracheostomies with shorter patient wait times, and performed a greater proportion of percutaneous tracheostomies at the bedside versus open tracheostomies in the operating room. The tracheostomy care team (TCT) received 91 consults over the course of 1 year with an average of 1.1 billable procedures generated per consult. Conclusion: In this study, an ENT hospitalist was decreased patient wait time to tracheostomy and increased bedside percutaneous tracheostomies, which has positive implications for resource utilization and healthcare cost. The average wait time to receive a tracheostomy was reduced when calculated across the entire department due to the availability of the ENT hospitalist to see and perform tracheostomies. The TCT generated many billable bedside procedures in addition to encouraged decannulation of patients. This study highlights the fact that the ENT hospitalist contributes to providing expedient tracheostomies and provides valuable consulting services as part of a TCT at a high-volume tertiary care facility.


2020 ◽  
Vol 6 (6) ◽  
pp. 125-130
Author(s):  
Dr. Chetna R Vaghela ◽  
◽  
Dr. Vipul Nanjibhai Sarvaiya ◽  

Introduction: The role of aspirin in the primary or secondary prevention of preeclampsia has beenthe subject of numerous studies and great controversy. Our aim reports on LDA usage rates bywomen with an increased PE risk, as well as on determinants and reasons given for use and non‐use. Material and Method: In this multicenter, double-blind, placebo-controlled trial, the currentstudy randomly assigned 2100 women with singleton pregnancies who were at high risk for pretermpreeclampsia to receive aspirin, at a dose of 150 mg per day, or placebo from 11 to 14 weeks ofgestation until 36 weeks of gestation. The primary outcome was delivery with preeclampsia before37 weeks of gestation. The analysis was performed according to the intention-to-treat principle.Results: Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as comparedwith 35 (4.3%) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval,0.20 to 0.74; P=0.004). Results were materially unchanged in a sensitivity analysis that took intoaccount participants who had withdrawn or were lost to follow-up. Conclusion: This randomizedtrial showed that among women with singleton pregnancies who were identified using first-trimesterscreening as being at high risk for preterm preeclampsia, the administration of aspirin at a dose of150 mg per day from 11 to 14 weeks of gestation until 36 weeks of gestation resulted in asignificantly lower incidence of preterm preeclampsia than that with placebo.


PEDIATRICS ◽  
1993 ◽  
Vol 92 (1) ◽  
pp. 187-188
Author(s):  
COLIN K. PHOON

To the Editor.— Having recently worked in a neonatal intensive care unit at a tertiary care facility, I read Dr Silverman's essay1 with great interest. His perception that many "seriously compromised" neonates are overtreated is justified. However, he emphasized the role of the medical profession In overtreatment, while he sided with parents who have been angry with and resentful of their child's outcome. Although the medical establishment can rightly be blamed for overtreatment in many instances, my experience with who exactly is overtreating is somewhat different.


2020 ◽  
Vol 11 (3) ◽  
pp. 3251-3260
Author(s):  
Makrand B Mane

Acute Myocardial Infarction (AMI) has become a significant public health issue in developed and developing nations, following extensive diagnostic and management research over recent decades. The study intended to research the prognostic values of inexplicable Hyponatremia in patients with severe STelevation of myocardial infarction, in 100 consecutive patients admitted to Tertiary care hospital. In the analysis, identified patients on admission were diagnosed with or produced Hyponatremia within 72 hours—a lower ejection fraction than those with usual amounts of sodium. The research aimed to evaluate the prognosis significance of Hyponatremia for the estimation of early death in acute ST-elevated myocardial infarction. One hundred straight patients admitted in the Coronary Centre Tertiary Care Facility with severe STelevated myocardial infarction were studied. The data of the study on various risk factors in association with the development of Hyponatremia like as age, sex, use of tobacco, diabetes, hypertension, ejection fraction etc. were analyzed. Thus, the researchers reported that in patients diagnosed with severe ST section escalation, Hyponatremia showed the initial emergence of hyponatremia myocardial infarctions. This condition correlates with the severity of LV dysfunction (in term of LVEF) and can be considered as an individual early death indicator as well as a prediction exacerbates with hyponatremia frequency.


Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1276
Author(s):  
Franka Neumer ◽  
Orenci Urraca ◽  
Joaquin Alonso ◽  
Jesús Palencia ◽  
Vicente Varea ◽  
...  

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.


2019 ◽  
Vol 71 (1) ◽  
Author(s):  
Hussein Hassan Rizk ◽  
Ahmed Adel Elamragy ◽  
Ghada Sayed Youssef ◽  
Marwa Sayed Meshaal ◽  
Ahmad Samir ◽  
...  

Abstract Background Few data are available on the characteristics of infective endocarditis (IE) cases in Egypt. The aim of this work is to describe the characteristics and outcomes of IE patients and evaluate the temporal changes in IE diagnostic and therapeutic aspects over 11 years. Results The IE registry included 398 patients referred to the Endocarditis Unit of a tertiary care facility with the diagnosis of possible or definite IE. Patients were recruited over two periods; period 1 (n = 237, 59.5%) from February 2005 to December 2011 and period 2 (n = 161, 40.5%) from January 2012 to September 2016. An electronic database was constructed to include information on patients’ clinical and microbiological characteristics as well as complications and mortality. The median age was 30 years and rheumatic valvular heart disease was the commonest underlying cardiac disease (34.7%). Healthcare-associated IE affected 185 patients (46.5%) and 275 patients (69.1%) had negative blood cultures. The most common complications were heart failure (n = 148, 37.2%), peripheral embolization (n = 133, 33.4%), and severe sepsis (n = 100, 25.1%). In-hospital mortality occurred in 108 patients (27.1%). Period 2 was characterized by a higher prevalence of injection drug use-associated IE (15.5% vs. 7.2%, p = 0.008), a higher staphylococcal IE (50.0% vs. 35.7%, p = 0.038), lower complications (31.1% vs. 45.1%, p = 0.005), and a lower in-hospital mortality (19.9% vs. 32.1%, p = 0.007). Conclusion This Egyptian registry showed high rates of culture-negative IE, complications, and in-hospital mortality in a largely young population of patients. Improvements were noted in the rates of complications and mortality in the second half of the reporting period.


2021 ◽  
Vol 10 (10) ◽  
pp. 2056
Author(s):  
Frank Herbstreit ◽  
Marvin Overbeck ◽  
Marc Moritz Berger ◽  
Annabell Skarabis ◽  
Thorsten Brenner ◽  
...  

Infections with SARS-CoV-2 spread worldwide early in 2020. In previous winters, we had been treating patients with seasonal influenza. While creating a larger impact on the health care systems, comparisons regarding the intensive care unit (ICU) courses of both diseases are lacking. We compared patients with influenza and SARS-CoV-2 infections treated at a tertiary care facility offering treatment for acute respiratory distress syndrome (ARDS) and being a high-volume facility for extracorporeal membrane oxygenation (ECMO). Patients with COVID-19 during the first wave of the pandemic (n = 64) were compared to 64 patients with severe influenza from 2016 to 2020 at our ICU. All patients were treated using a standardized protocol. ECMO was used in cases of severe ARDS. Both groups had similar comorbidities. Time in ICU and mortality were not significantly different, yet mortality with ECMO was high amongst COVID-19 patients with approximately two-thirds not surviving. This is in contrast to a mortality of less than 40% in influenza patients with ECMO. Mortality was higher than estimated by SAPSII score on admission in both groups. Patients with COVID-19 were more likely to be male and non-smokers than those with influenza. The outcomes for patients with severe disease were similar. The study helps to understand similarities and differences between patients treated for severe influenza infections and COVID-19.


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